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Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: subgroup analyses of the phase 3 POLLUX study

机译:东亚复发或难治性多发性骨髓瘤患者中的Daratumumab,来那度胺和地塞米松:POLLUX 3期研究的亚组分析

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In the phase 3 POLLUX study, daratumumab plus lenalidomide and dexamethasone (DRd) significantly reduced the risk of progression/death and induced deeper responses vs. lenalidomide and dexamethasone alone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM). We report a subgroup analysis of East Asian (Japanese, Korean, and Taiwanese) patients from POLLUX based on a longer follow-up of 24.7 months. Median progression-free survival was not reached (NR) for DRd vs. 13.8 months for Rd (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.23–0.76), and overall response rates were higher for DRd vs. Rd (90.2 vs. 72.1%). DRd extended the median duration of response vs. Rd (NR vs. 20.2 months), and minimal residual disease–negative rates at the 10–5 sensitivity threshold were 21.2 vs. 9.1% for DRd vs. Rd. No new safety signals were observed. Similar efficacy and safety were observed in the smaller subgroup of Japanese patients treated with DRd vs. Rd. These results demonstrate favorable efficacy and safety of DRd vs. Rd in East Asian patients and also in the Japanese-only patient subgroup that are consistent with findings in the overall patient population of POLLUX.
机译:在POLLUX的3期研究中,与单独使用来那度胺和地塞米松(Rd)相比,达那妥单抗联合来那度胺和地塞米松(DRd)显着降低了复发/难治性多发性骨髓瘤(RRMM)患者的发展/死亡风险,并引起了更深的反应。我们报告了基于24.7个月的较长随访的POLLUX对东亚(日本,韩国和台湾)患者的亚组分析。 DRd的中位无进展生存期未达到(NR),Rd的中位无进展生存期为13.8个月(风险比[HR]为0.42; 95%置信区间[CI]为0.23-0.76),DRd的总体缓解率高于Rd(90.2比72.1%)。 DRd延长了相对于Rd的中位反应持续时间(NR vs. 20.2个月),DRd vs. Rd的最小残留疾病阴性率为10-5敏感度阈值为21.2 vs. 9.1%。没有观察到新的安全信号。在接受DRd vs. Rd治疗的日本较小患者中,观察到相似的疗效和安全性。这些结果证明了DRd vs. Rd在东亚患者以及仅在日本的患者亚组中具有良好的疗效和安全性,这与POLLUX总体患者群体的发现一致。

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